Developing the Covid-19 vaccine

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shpalman
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Re: Developing the Covid-19 vaccine

Post by shpalman » Sat Jan 16, 2021 6:39 pm

jdc wrote:
Sat Jan 16, 2021 6:20 pm
Here we go. It's in your NEJM link. One trial, several cohorts.
The trial was initiated on July 22, 2020, at 12 centers in Belgium and the United States. Trial participants included healthy adults between the ages of 18 and 55 years and those 65 years of age or older. The younger group was divided into cohort 1a (with a target enrollment of 375 participants) and cohort 1b (an exploratory cohort for in-depth analysis of immunogenicity, with a target enrollment of 25 participants). The older age group was included in cohort 3, with a target enrollment of 375 participants. In November 2020, enrollment was initiated in cohort 2 to collect longer-term data comparing a single-dose regimen with a two-dose regimen
Well there could be a Phase III trial running on the protocol from the trial which started in July, but I had in mind that the new news was the efficacy of the vaccine even with just one dose'; if that bit started in November and is intended to be "longer term" they can't possibly have Phase III data about that regime by the end of February can they?
molto tricky

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Re: Developing the Covid-19 vaccine

Post by jdc » Sat Jan 16, 2021 7:19 pm

I thought the Phase III trial of one dose started in September and Phase III for 1 v 2 dose started in November so were Cohorts 1 and 3 in the Phase I/II trial given a single dose and Cohort 2 in that trial either split into 1v2 to compare or given 2 doses to compare with cohorts 1& 3?

I think all I've established for certain so far is that I'm finding this confusing.

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Sat Jan 16, 2021 8:44 pm

In Norway there have been 23 reports of possible deaths due to adverse reactions to the Pfizer vaccine.
Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail

23 deaths associated with covid-19 vaccination of which 13 have been assessed. Common adverse reactions may have contributed to a severe course in elderly people who are frail.

Publisert: 15.01.2021

All reports of suspected adverse reactions with fatal outcome following vaccination are carefully assessed.

- The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.

The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness - and included few participants over 85 years of age. In Norway we are now vaccinating the elderly and people in nursing homes with serious underlying diseases, therefore it is expected that deaths close to the time vaccination may occur. In Norway, an average of 400 people die each week in nursing homes and long-term care facilities.

All deaths that occur within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination (such as fever and nausea) may contribute to more serious course and fatal outcome in patients with severe underlying disease.

The Norwegian Medicines Agency and the National Institute of Public Health jointly assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.

As of 14 January, 23 reports of suspected deaths have been submitted to the Norwegian ADR health registry. The figures in the published report include the thirteen reports that have been assessed by the Norwegian Medicines Agency and the National Institute of Public Health. Several reports of suspected adverse reactions are received on a daily basis and are continuously assessed.
https://legemiddelverket.no/nyheter/cov ... -are-frail

There have so far been 517 Covid deaths in the country. So 23 would be a large proportion of that. Though of course we will have to wait until the reports have been investigated. As mentioned above as the most vulnerable people were being vaccinated first the deaths could have been a coincidence.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sun Jan 17, 2021 2:39 am

shpalman wrote:
Sat Jan 16, 2021 5:48 pm

I think it'll show that it's about 90% effective because just about all of the decent "Western" vaccines are, including maybe even the Oxford/AstraZeneca one assuming you use the "wrong" dose regime and not the officially approved one.
I have to admit, I was very disappointed in the efficacy results from the Sinovac vaccine.
I don't understand the numbers from Astra Zeneca and some people in Australia are saying it should not be used.
https://www.msn.com/en-au/news/australi ... i-BB1cHbQ4

Lets hope J&J is better.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sun Jan 17, 2021 2:57 am

Woodchopper wrote:
Sat Jan 16, 2021 8:44 pm
In Norway there have been 23 reports of possible deaths due to adverse reactions to the Pfizer vaccine.
Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail

23 deaths associated with covid-19 vaccination of which 13 have been assessed. Common adverse reactions may have contributed to a severe course in elderly people who are frail.

Publisert: 15.01.2021

All reports of suspected adverse reactions with fatal outcome following vaccination are carefully assessed.

- The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.

The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness - and included few participants over 85 years of age. In Norway we are now vaccinating the elderly and people in nursing homes with serious underlying diseases, therefore it is expected that deaths close to the time vaccination may occur. In Norway, an average of 400 people die each week in nursing homes and long-term care facilities.

All deaths that occur within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination (such as fever and nausea) may contribute to more serious course and fatal outcome in patients with severe underlying disease.

The Norwegian Medicines Agency and the National Institute of Public Health jointly assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.

As of 14 January, 23 reports of suspected deaths have been submitted to the Norwegian ADR health registry. The figures in the published report include the thirteen reports that have been assessed by the Norwegian Medicines Agency and the National Institute of Public Health. Several reports of suspected adverse reactions are received on a daily basis and are continuously assessed.
https://legemiddelverket.no/nyheter/cov ... -are-frail

There have so far been 517 Covid deaths in the country. So 23 would be a large proportion of that. Though of course we will have to wait until the reports have been investigated. As mentioned above as the most vulnerable people were being vaccinated first the deaths could have been a coincidence.
Is this happening only in Norway or is the info being surpressed in other countries?

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Re: Developing the Covid-19 vaccine

Post by tom p » Tue Jan 19, 2021 6:21 pm

jdc wrote:
Sat Jan 16, 2021 7:19 pm
I thought the Phase III trial of one dose started in September and Phase III for 1 v 2 dose started in November so were Cohorts 1 and 3 in the Phase I/II trial given a single dose and Cohort 2 in that trial either split into 1v2 to compare or given 2 doses to compare with cohorts 1& 3?

I think all I've established for certain so far is that I'm finding this confusing.
The EMA is currently conducting a rolling review of the JnJ vaccine

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Re: Developing the Covid-19 vaccine

Post by tom p » Tue Jan 19, 2021 6:23 pm

Herainestold wrote:
Sun Jan 17, 2021 2:57 am
Woodchopper wrote:
Sat Jan 16, 2021 8:44 pm
In Norway there have been 23 reports of possible deaths due to adverse reactions to the Pfizer vaccine.
Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail

23 deaths associated with covid-19 vaccination of which 13 have been assessed. Common adverse reactions may have contributed to a severe course in elderly people who are frail.

Publisert: 15.01.2021

All reports of suspected adverse reactions with fatal outcome following vaccination are carefully assessed.

- The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.

The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness - and included few participants over 85 years of age. In Norway we are now vaccinating the elderly and people in nursing homes with serious underlying diseases, therefore it is expected that deaths close to the time vaccination may occur. In Norway, an average of 400 people die each week in nursing homes and long-term care facilities.

All deaths that occur within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination (such as fever and nausea) may contribute to more serious course and fatal outcome in patients with severe underlying disease.

The Norwegian Medicines Agency and the National Institute of Public Health jointly assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.

As of 14 January, 23 reports of suspected deaths have been submitted to the Norwegian ADR health registry. The figures in the published report include the thirteen reports that have been assessed by the Norwegian Medicines Agency and the National Institute of Public Health. Several reports of suspected adverse reactions are received on a daily basis and are continuously assessed.
https://legemiddelverket.no/nyheter/cov ... -are-frail

There have so far been 517 Covid deaths in the country. So 23 would be a large proportion of that. Though of course we will have to wait until the reports have been investigated. As mentioned above as the most vulnerable people were being vaccinated first the deaths could have been a coincidence.
Is this happening only in Norway or is the info being surpressed in other countries?
Other countries aren't China.
All side effects to all medicines in Europe are available from adrreports.eu, something anyone who wasn't a lazy tw.t could find out with a few mouse clicks

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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Jan 19, 2021 6:33 pm

molto tricky

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Re: Developing the Covid-19 vaccine

Post by Millennie Al » Wed Jan 20, 2021 1:34 am

tom p wrote:
Tue Jan 19, 2021 6:23 pm
All side effects to all medicines in Europe are available from adrreports.eu, something anyone who wasn't a lazy tw.t could find out with a few mouse clicks
That's www.adrreports.eu and I cannot find the Pfizer vaccine there at all under the names BNT162b2, Comirnaty, or tozinameran.
Covid-19 - Don't catch it: don't spread it.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Wed Jan 20, 2021 5:00 am

Metro Manila (CNN Philippines, January 19) — President Rodrigo Duterte took a jab at senators who favored the vaccines produced by Pfizer-BioNTech after the deaths of some elderly patients in Norway who took a shot against COVID-19.

“Ang Pfizer ng mga senador (The Pfizer for the senators)...25 died after receiving their vaccines. There you are, mamili kayo (you choose),” said Duterte during his weekly national address on Monday.

He added that China-made Sinovac vaccine is now being used in neighboring countries like Thailand, Malaysia, Indonesia, as well as in Turkey, Egypt, and UAE, claiming that there were no reported deaths after being vaccinated with it.

“Almost everybody na kilala ko are scrambling to buy itong Pfizer (Almost everybody that I know want to buy Pfizer). To me it is a good one. If you want to follow the experience of Norway, go ahead, nobody will stop you,” said Duterte.
https://cnnphilippines.com/news/2021/1/ ... fizer.html

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Re: Developing the Covid-19 vaccine

Post by tom p » Wed Jan 20, 2021 8:42 am

Millennie Al wrote:
Wed Jan 20, 2021 1:34 am
tom p wrote:
Tue Jan 19, 2021 6:23 pm
All side effects to all medicines in Europe are available from adrreports.eu, something anyone who wasn't a lazy tw.t could find out with a few mouse clicks
That's www.adrreports.eu and I cannot find the Pfizer vaccine there at all under the names BNT162b2, Comirnaty, or tozinameran.
Search under substances and go to COVID-19.
All COVID vaccines will start "COVID-19" so they are all together.
Within a day or two, there will be a box or some bold text at the index page that everyone has to go through that will point to the correct page and tell the user what to search for. It's just being translated into all languages first
Last edited by tom p on Wed Jan 20, 2021 8:45 am, edited 1 time in total.

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Re: Developing the Covid-19 vaccine

Post by Gfamily » Wed Jan 20, 2021 8:44 am

Millennie Al wrote:
Wed Jan 20, 2021 1:34 am
tom p wrote:
Tue Jan 19, 2021 6:23 pm
All side effects to all medicines in Europe are available from adrreports.eu, something anyone who wasn't a lazy tw.t could find out with a few mouse clicks
That's www.adrreports.eu and I cannot find the Pfizer vaccine there at all under the names BNT162b2, Comirnaty, or tozinameran.
If you look under Substances, it's there under COVID-19 MNRA VACCINE
My avatar was a scientific result that was later found to be 'mistaken' - I rarely claim to be 100% correct
ETA 5/8/20: I've been advised that the result was correct, it was the initial interpretation that needed to be withdrawn
Meta? I'd say so!

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Re: Developing the Covid-19 vaccine

Post by shpalman » Thu Jan 21, 2021 7:59 pm

Model-informed COVID-19 vaccine prioritization strategies by age and serostatus
Limited initial supply of SARS-CoV-2 vaccine raises the question of how to prioritize available doses. Here, we used a mathematical model to compare five age-stratified prioritization strategies. A highly effective transmission-blocking vaccine prioritized to adults ages 20-49 years minimized cumulative incidence, but mortality and years of life lost were minimized in most scenarios when the vaccine was prioritized to adults over 60 years old. Use of individual-level serological tests to redirect doses to seronegative individuals improved the marginal impact of each dose while potentially reducing existing inequities in COVID-19 impact. While maximum impact prioritization strategies were broadly consistent across countries, transmission rates, vaccination rollout speeds, and estimates of naturally acquired immunity, this framework can be used to compare impacts of prioritization strategies across contexts.
DOI: 10.1126/science.abe6959
molto tricky

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Re: Developing the Covid-19 vaccine

Post by Millennie Al » Fri Jan 22, 2021 1:50 am

tom p wrote:
Wed Jan 20, 2021 8:42 am
Search under substances and go to COVID-19.
All COVID vaccines will start "COVID-19" so they are all together.
Within a day or two, there will be a box or some bold text at the index page that everyone has to go through that will point to the correct page and tell the user what to search for. It's just being translated into all languages first
Found it. Thanks. I see there's 168 deaths, though I don't know how many vaccinated people that covers - obviously quite a lot as a search for "serious" reports produces 1044 records from the EEA and 1833 from Non EEA.
Covid-19 - Don't catch it: don't spread it.

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Re: Developing the Covid-19 vaccine

Post by tom p » Fri Jan 22, 2021 9:19 am

Millennie Al wrote:
Fri Jan 22, 2021 1:50 am
tom p wrote:
Wed Jan 20, 2021 8:42 am
Search under substances and go to COVID-19.
All COVID vaccines will start "COVID-19" so they are all together.
Within a day or two, there will be a box or some bold text at the index page that everyone has to go through that will point to the correct page and tell the user what to search for. It's just being translated into all languages first
Found it. Thanks. I see there's 168 deaths, though I don't know how many vaccinated people that covers - obviously quite a lot as a search for "serious" reports produces 1044 records from the EEA and 1833 from Non EEA.
It covers the entire world, so however many have been vaccinated in total.
It needs to be borne in mind that (a) these are suspicions of being caused by the vaccine, and that suspicion can be defined pretty loosely (ie just loose chronology) and (b) pretty much the whole (wealthy part of the) world has taken the same approach as the UK - vaccinate the elderly and infirm first. This population has a high rate of death per annum (COVID kills lots of them and fewer of everyone else 'cos it basically gives you your year's chance of dying within 2 weeks or so) and so it's possible that every one of them would have died then anyway.
The drug companies are obliged to tell regulators everything. National regulators in the EEA are obliged to tell the EMA everything. So this is a distillation of all that is known. All suspicions, no matter how weak, are required to be sent in because then all the national regulators and the EMA have full access to everything and can investigate everything thoroughly before taking a view

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Re: Developing the Covid-19 vaccine

Post by shpalman » Mon Jan 25, 2021 9:26 pm

molto tricky

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Re: Developing the Covid-19 vaccine

Post by Grumble » Mon Jan 25, 2021 10:36 pm

Gah, you’ve linked to a live page rather than the actual story.

Anyway, having found the story it’s from Bild, so I’m not sure how seriously to take it.
I know this is vitriol, no solution, spleen venting, but I feel better having screamed, don’t you?

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Re: Developing the Covid-19 vaccine

Post by shpalman » Mon Jan 25, 2021 10:56 pm

Grumble wrote:
Mon Jan 25, 2021 10:36 pm
Gah, you’ve linked to a live page rather than the actual story.

Anyway, having found the story it’s from Bild, so I’m not sure how seriously to take it.
Well I've seen roughly the same amount and quality of evidence for this as I have the claim that the AstraZeneca vaccine is 70% effective when there's 12 weeks between doses.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by jdc » Tue Jan 26, 2021 12:24 am

Reuters report the Bild story and AZ's rebuttal: https://www.reuters.com/article/us-heal ... SKBN29U2D9
German daily papers Handelsblatt and Bild said in separate reports the vaccine - co-developed by AstraZeneca and Oxford University - had an efficacy of 8% or less than 10%, respectively, in those over 65.
In a written response, AstraZeneca described the German media reports saying its COVID-19 vaccine was shown to have a very low efficacy in the elderly as “completely incorrect”.

It said Britain’s Joint Committee on Vaccination and Immunisation supported the vaccine’s use in the elderly. It also said that a strong immune responses to the vaccine had been shown in blood analysis of elderly trial participants.
And further down:
Elderly trial participants were recruited later so that infections, which are needed to arrive at reliable efficacy data, were also coming in later.

Researchers at Oxford University said in a paper published in medical journal The Lancet on Dec. 8, when details of key vaccine trials held in Britain and Brazil were released, that efficacy data based on infections in the elderly were still limited.

“Efficacy data in these cohorts are currently limited by the small number of (infection) cases, but additional data will be available in future analyses,” they said in the paper.
So... I think the only figures we have seen on efficacy in over-65s so far are from Handelsblatt and Bild. And afaict AZ are basing their rebuttal on (a) what JCVI reckon and (b) antibody levels in the oldies in their trial(s) and the only thing they've published on efficacy in oldies is from 8th Dec when they let us know they didn't have the data yet.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Tue Jan 26, 2021 5:34 am

That would be a bummer if oldies in the UK turned down the 95% efficacious Pfizzer vax to get the British AZ jab with 8% efficacy.

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Re: Developing the Covid-19 vaccine

Post by Grumble » Tue Jan 26, 2021 7:28 am

So Handelsblatt and Bild have based their story on precisely nothing.
I know this is vitriol, no solution, spleen venting, but I feel better having screamed, don’t you?

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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Jan 26, 2021 9:46 am

For all we know, JCVI and AstraZeneca aren't basing their "oh yes it is" on anything either.

In the actual published data we note that the group who accidentally got the LD/SD dose were all 18-55, the efficacy was 90.0%, whereas in the UK SD/SD group it was 60.3% if including the whole age range but 65.6% if limiting to 18-55 to match the LD/SD subgroup.

i.e. COV002 (UK) SD/SD age 18-55 had 34 covid cases of which 8/1407 in the vaccine group and 26/1512 in the control (Table 3).

This would already be a subset of a subset because I note from Table 1 that COV002 (UK; SD/SD) had 1879 and 1922 subjects in the 18-55 range in the vaccine and control groups respectively. The numbers match more closely with the "Health and social care setting workers" (1441 and 1513) and Table 3 does indicate that the models have been adjusted for "BMI (<30 vs ≥30 kg/m2), health-care worker status (yes vs no), and ethnicity (white vs non-white)".

But the COV002 (UK) SD/SD results presented in Table 2 give 15/2377 and 38/2430 cases in vaccine and control groups respectively.

You can't just subtract the Table 3 results from the Table 2 results to get the cases in the >55 age range, because of whatever the f.ck they've done to the data in Table 3, but if you could it would be 7/970 and 12/918.

Because all we can do is make up numbers since we have no idea what data AstraZeneca and the JCVI are looking at.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Jan 26, 2021 10:28 am

Meanwhile also Sweden has noticed that it's taking the piss for Pfizer to now charge more for a phial of vaccine if six doses can be extracted from it instead of five. i.e. Pfizer want to maintain the same price per dose even if depending on the kind of syringe you have, you can get more doses out of a phial.
shpalman wrote:
Sun Jan 24, 2021 1:26 pm
... (I read something about if Italy and other EU countries were indeed able to get six doses out of a phial instead of five thanks to using a more efficient syringe, then Pfizer would increase the price per box of phials by a factor of 6/5... that would be taking the piss a bit.)
molto tricky

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Re: Developing the Covid-19 vaccine

Post by lpm » Tue Jan 26, 2021 11:08 am

There's a lot of international tension right now. Limited supply of life-saving medicine being fought over by desperate countries.

The answer is of course to eliminate countries and have one global people.

However I'm not sure I can get that done in the next month or two. The second best method would be for supplies to be shared internationally according to population size >80, then >70, and so on down the cohorts.

Aren't there Star Trek episodes and the like where conflict due to limited medicine is the basic plot line?
What ever happened to that Trump guy, you know, the one who was president for a bit?

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Re: Developing the Covid-19 vaccine

Post by headshot » Tue Jan 26, 2021 11:29 am

lpm wrote:
Tue Jan 26, 2021 11:08 am
Aren't there Star Trek episodes and the like where conflict due to limited medicine is the basic plot line?
There's one episode (Symbiosis) where a population is convinced that they'll die if they don't receive life saving medicines supplied exclusively by a neighbouring planet, but it turns out the neighbouring planet has in fact hooked the users on a highly addictive drug with terrible withdrawal symptoms. Picard sorts it all out...by doing nothing.

https://en.wikipedia.org/wiki/Symbiosis ... eneration)

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